Clinical Data Manager (Berkeley Heights)

About Kalaris

Kalaris Therapeutics is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs.

Kalaris’ lead asset, TH103, was developed by Lasker Award winner, Dr. Napoleone Ferrara, a pioneer in the field of VEGF research, and the inventor of Lucentis and Avastin during his time at Genentech. TH103 is a novel, clinical stage anti-vascular endothelial growth factor (VEGF) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases.

In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current market-leading anti-VEGF agent. In a Phase 1a single ascending dose trial, TH103 was generally well tolerated and showed a potent anti-VEGF effect on functional and anatomical outcomes at 1-month post-dosing. Single dose durability signals, including pharmacokinetic analysis and retreatment results, suggest that TH103 may offer extended treatment durability outcomes after a standard four-dose loading regimen. Kalaris is currently enrolling a Phase 1b/2 Multiple Ascending Dose trial of TH103 in patients with nAMD, to help assess the safety and efficacy of repeat TH103 administration and to inform dose selection for potential Phase 3 development.

Kalaris’ board of directors, management team and investors include co-founders, scientists and leaders and investors from companies that have played pivotal roles in developing retina therapeutics.

About nAMD

nAMD is a leading cause of blindness in the United States and Europe that affected an estimated 1.6 million adults in the United States in 2024. Over the past 20 years, anti-VEGF therapeutics have revolutionized the treatment of prevalent exudative and/or neovascular retinal diseases, which represented an estimated $15 billion global branded market in 2024. While clinical trials for these drugs have shown improvements in mean visual acuity, these results often are not reproduced in real-world settings. Many patients find the treatment burden to be challenging because it requires a demanding schedule of clinic visits and years of monitoring and treatments. This onerous treatment burden can lead to a lack of adherence to the frequent visit regimen and a decline in vision after initial gains.

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The Clinical Data Manager , in collaboration with study lead, is responsible for the oversight and execution of clinical data management activities across one or more clinical programs. This role ensures the timely delivery of high-quality, accurate, complete, and inspection-ready clinical trial data in compliance with applicable regulatory requirements, industry standards, and study timelines.

This role serves as a key liaison across Clinical Operations, Biostatistics, Medical, Safety, Regulatory, Quality, CROs, and external data vendors. The Clinical Data Manager provides sponsor oversight of outsourced data management activities and drives database development, data cleaning, reconciliation, data cuts, database lock, and other data deliverables required to support clinical development and regulatory milestones.

Job Description and Specific Responsibilities

Clinical Data Management Strategy & Study Execution

• Lead and/or oversee data management activities for assigned clinical studies from study start-up through database lock and archival.
• Serve as the primary sponsor data management point of contact for CROs, clinical vendors, and internal cross-functional study teams.
• Develop, review, and/or approve study-specific data management documentation, including Data Management Plans, Data Validation Plans, Data Review Plans, CRF Completion Guidelines, and related documentation.
• Participate in the design, development, review, testing, and implementation of electronic case report forms (eCRFs), clinical databases, edit checks, and associated study specifications.
• Review clinical protocols and amendments from a data management perspective and assess impacts to eCRFs, database design, edit checks, data transfers, and existing study data.

Database Development, Data Review & Cleaning

• Lead and/or oversee User Acceptance Testing (UAT) of clinical databases, database updates, and related data management systems.
• Monitor data entry, query management, data cleaning, and data quality metrics to ensure study data are complete, accurate, and available within required timelines.
• Perform and/or oversee ongoing data review and proactively identify data trends, inconsistencies, risks, and issues requiring resolution or escalation.
• Drive data-cleaning activities in preparation for interim analyses, data cuts, database freezes, and final database locks.
• Coordinate database lock activities and ensure completion of required data reviews, reconciliations, documentation, and approvals.
• Partner with Clinical Operations and study teams to identify and resolve site-level data entry, query, and data quality issues.

External Data & Reconciliation

• Oversee the collection, transfer, integration, and reconciliation of external data, including laboratory, imaging, pharmacokinetic, safety, IRT/RTSM, and other third-party vendor data.
• Develop and/or review Data Transfer Agreements, transfer specifications, and schedules in collaboration with internal functions, CROs, and external vendors.
• Ensure external data transfers are received, reviewed, reconciled, and integrated according to agreed specifications and timelines.

CRO, Vendor & Timeline Management

• Provide sponsor oversight of CRO and vendor data management activities, deliverables, timelines, and performance.
• Participate in vendor selection, scope development, and review of data management assumptions and proposals, as applicable.
• Track key data management milestones and metrics and proactively communicate risks, dependencies, and mitigation plans to the study team.
• Serve as an escalation point for data management, data quality, and vendor-related issues and drive issues through timely resolution.

Compliance & Inspection Readiness

• Ensure clinical data management activities comply with GCP, ICH guidelines, applicable regulatory requirements, company SOPs, and industry standards.
• Support regulatory inspections and audits and represent Clinical Data Management, as appropriate.
• Maintain TMF readiness and ensure appropriate filing and traceability of data management documentation and decisions.
• Actively participate in the development and maintenance of relevant SOPs, work instructions, templates, working practices, and plans.

Cross-Functional Leadership

• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/Pharmacovigilance, Regulatory Affairs, and Quality to support study and program objectives.
• Partner with Biostatistics and Statistical Programming to ensure clinical data are appropriately prepared for analyses, tables/listings/figures, clinical study reports, and regulatory submissions.
• Communicate data status, key metrics, risks, issues, and upcoming milestones clearly and effectively to study teams and internal stakeholders.

Qualifications/Experience

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, Data Management, or a related field with 5+ years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry.
• Strong knowledge of clinical data management principles, GCP, ICH guidelines, applicable regulatory requirements, and 21 CFR Part 11.
• Demonstrated experience with EDC systems, eCRF/database development, edit checks, UAT, data cleaning, query management, and database lock.
• Experience managing and reconciling external clinical data, including laboratory, imaging, safety, IRT/RTSM, and other vendor data.
• Experience providing sponsor oversight of outsourced CRO and vendor data management activities.
• Working knowledge of CDISC standards, including CDASH and SDTM, is preferred.
• Strong project management, problem-solving, risk identification, and issue-resolution capabilities.
• Excellent written and verbal communication skills; able to collaborate effectively across functions and with external partners.
• Highly organized, detail-oriented, and capable of managing multiple concurrent priorities and study deliverables. Proficiency in Microsoft Office, including Excel, is required; ophthalmology clinical trial experience is a plus.

Additional Details

This role is hybrid and will require periodic travel to clinical vendors, CRO meetings, investigator meetings, or other business-related activities. This role also requires multiple overnight days of monthly travel to on-site meetings in Berkeley Heights, NJ for clinical team and company meetings. The travel time is expected to be approximately 25% of the total working hours.

The salary range for this position is $117,000 USD to $145,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

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